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Biosimilars Forum Statement: FDA Arthritis Advisory Committee Meeting for Biosimilar to Remicade (Infliximab), Submitted by Celltrion, Inc.

Washington, D.C. February 9, 2016 –The Biosimilars Forum provided testimony today at the FDA Arthritis Advisory Committee meeting on the biologics license application (BLA) for Remsima the proposed biosimilar to Remicade (infliximab) submitted by Celltrion, Inc. The summary of the Biosimilars Forum’s testimony is below.

Biosimilars Forum’s Testimony to the FDA Arthritis Advisory Committee Meeting

“The founding members of the Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios. In fact, about 70% of the 57 proposed biosimilar products currently in development with the FDA are sponsored by members of the Forum.

Members of the Forum recognize there is a need for a sustained and unbiased biosimilars education and advocacy program in the U.S. That’s why since its inception, the Forum has worked collaboratively with FDA on policy issues as well as designing mechanisms to educate physicians and patients about the science behind biosimilars.

Vital to our goal is the ability for biosimilar sponsors to engage with FDA and have a productive dialogue leading to timely product approvals. 2015 was a watershed year, as the agency approved the first ever biosimilar medicine for the US market. In 2016, we anticipate the review and approval of several more biosimilars, possibly including the first ever interchangeable biosimilar medicine.

The introduction of biosimilars in the U.S. can help expand access to high-quality treatment options for clinicians and patients as well as reduce costs to families, caregivers, payers, and the health care system.”

The timing of this FDA advisory board meeting is important as the Biosimilars Forum just launched the Partnership for Biosimilars Education and Access, with the focus on raising awareness and encouraging access to biosimilars in the United States.

Organizations wishing to collaborate with the Biosimilars Forum on the Partnership for Biosimilars Education initiative, are encouraged to contact the Biosimilars Forum at http://www.biosimilarsforum.org/contact-us, or via Twitter @USbiosimilars.


About the Biosimilars Forum

The Biosimilars Forum is a nonprofit organization whose mission is to advance biosimilars in the United States with the intent of expanding access and availability of biological medicines, and improving health care. The founding members of the Biosimilars Forum represent the majority of companies with the most significant U.S. biosimilars development portfolios.

To learn more about biosimilars, the Forum, and how to get involved, visit BiosimilarsForum.org or go to @USBiosimilars to follow related conversations and join the dialogue.

Contact:
Aimee Steel
202.828.1895
aimee.steel@hklaw.com

Media:
Lynn Blenkhorn
508.851.0930
biosimilars@fkhealth.com

Date

Tuesday, February 9, 2016